Effects of supervised structured aerobic exercise training (SSAET) on patients with type 2 diabetes mellitus compared with routine medical management

ISRCTN	ISRCTN16466697
DOI	https://doi.org/10.1186/ISRCTN16466697
Secondary identifying numbers	1

Submission date: 13/04/2015
Registration date: 12/12/2016
Last edited: 24/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Diabetes is a condition that causes a person’s blood sugar level to become too high. Insulin is the hormone made by beta-cells in the pancreas and controls the amount of glucose in the blood. In type 2 diabetes, the body does not produce enough insulin for it to work properly or the body cells do not react properly to insulin (insulin resistance). People are more likely to develop diabetes if they are overweight, do not exercise, eat an unhealthy diet or are of an older age. People with type 2 diabetes are usually treated by oral medication, insulin therapy and lifestyle interventions, such as doing more exercise and eating healthily. Unfortunately, over time many patients will develop insulin resistance and stop responding to oral medicine or insulin therapy. There is a lot of evidence which supports the importance and effectiveness of exercise and physical activity in patients with type 2 diabetes. Exercise helps to stabilise blood glucose levels, maintain a healthy weight and reduce insulin resistance in patients. However, there is no ‘gold standard’ exercise plan for patients with type 2 diabetes. This is because there is not enough evidence to determine the best type, intensity, duration or frequency of exercise for patients. The aim of this study is to see what effect a structured, long-term exercise plan has on patients with type 2 diabetes.

Who can participate?
Patients aged 30-70 with type 2 diabetes

What does the study involve?
Participants are randomly allocated into one of two groups. One group receives routine medication and a diet plan. The other group receives routine medication, a diet plan, and participates in 25 weeks of supervised and structured aerobic exercise (treadmill exercise). Both groups are assessed for their blood sugar and insulin levels, cholesterol, weight, breathlessness, blood pressure and complications, if any.

What are the possible benefits and risks of participating?
The results of this study will help patients manage their diabetes and reduce symptoms. There are no risks associated with participating in this study.

Where is the study run from?
Riphah Rehabilitation Centre (Pakistan)

When is the study starting and how long is it expected to run for?
January 2015 to June 2016

Who is funding the study?
Riphah International University (Pakistan)

Who is the main contact?
Mr S Shakil-ur-Rehman
shakil.urrehman@riphah.edu.pk

Contact information

Mr Syed Shakil-ur-Rehman
Scientific

Riphah College of Rehabilitation Sciences
274 main Peshawar Road
Rawalpindi
46000
Pakistan

ORCID ID	0000-0002-6682-9896
Phone	+92 320 7866611
Email	shakil.urrehman@riphah.edu.pk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Effects of supervised structured aerobic exercise training (SSAET) on patients with type 2 diabetes mellitus compared with routine medical management: a randomised controlled trial
Study objectives	SSAET enhances treatment, affects biomarkers and improves the overall health status of patients with type 2 diabetes mellitus compared to routine medical management alone.
Ethics approval(s)	Ethics Committee University of Lahore, Pakistan, 10/03/2015, ref: IRB-UOL/00314/0A35
Health condition(s) or problem(s) studied	Diabetes mellitus type 2
Intervention	1. The control group received routine medication and dietary plan (non-exercised group) 2. The experimental group received the SSAET program, routine medication and dietary plan (exercise group). Patients in the experimental group will be subjected to long-term (25 weeks) supervised and structured aerobic exercise (SSAE) training (treadmill activity). The effect of supervised, and structured aerobic exercises training (treadmill activity) will be studied on glycaemic control, insulin in blood, aerobic capacity, cholesterol, proteins and enzymes in muscles, waist, weight, body mass index, level of exertion, breathlessness during physical activity, blood pressure and complications if any in such patients.
Intervention type	Behavioural
Primary outcome measure	1. Insulin resistance, measured using the HOMA Method 2. Glycemic control (HbA1c), measured using a kit 3. Plasma insulin level, measured using a kit 4. Fasting blood glucose level, estimated by glucometer Measured at baseline and at the completion of 6 month (25 weeks) intervention.
Secondary outcome measures	1. LDL and HDL cholesterol, measured from blood by using kits 2. Aerobic capacity (VO2 peak), measured by resting heart rate based method 3. Body weight 4. Body mass index (BMI) 5. Level of exertion, measured using the Borge scale 6. Dyspnea, measured by dyspnea index 7. Blood pressure, measured by BP apparatus 8. Post diabetic complications, measured by physical examination 9. Inflammatory markers, measured by Human ELISA Kits Measured at baseline and at the completion of 6 month (25 weeks) intervention.
Overall study start date	01/01/2015
Completion date	30/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Patients with type 2 diabetes mellitus diagnosed as per WHO criteria 2. Established diagnosis of type 2 diabetes mellitus with 1 year history 3. Age 30-70 4. No other post-diabetic complications or comorbidity 5. No prior history of regular physical exercise
Key exclusion criteria	1. Patients with type 1 diabetes mellitus or pregnancy induced diabetes 2. Aged less than 30/more than 70 3. Patients with any other post-diabetic complications or comorbidity 4. Musculoskeletal, cardiopulmonary or neurological problems. 5. Smokers 6. Patients with type 2 diabetes mellitus with a history of regular exercise
Date of first enrolment	01/01/2015
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

Pakistan

Study participating centre

Riphah Rehabilitation Centre

IIMCT Pakistan Railways General Hospital
Rawalpindi
46000
Pakistan

Sponsor information

Riphah International University
University/education

274 main Peshawar Road
Rawalpindi
46000
Pakistan

Phone	+92 (0)51 111 510 510
Email	rare@riphah.edu.pk
Website	www.riphah.edu.pk
"ROR"	https://ror.org/02kdm5630

Funders

Funder type

University/education

Riphah International University

No information available

Results and Publications

Intention to publish date	30/06/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Findings will be published in four research papers.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/01/2017	24/01/2019	Yes	No
Results article	results	18/05/2016	24/01/2019	Yes	No
Results article	results	01/11/2017	24/01/2019	Yes	No
Results article	results	01/06/2017	24/01/2019	Yes	No
Results article	results	01/10/2018	24/01/2019	Yes	No

Editorial Notes

24/01/2019: Publication references added